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Report of the Psychosocial Outcomes Workgroup of the Nursing and Social Sciences Council of the International Society for Heart and Lung Transplantation: Present Status of Research on Psychosocial Outcomes in Cardiothoracic Transplantation: Review and Recommendations for the Field
Department of Psychiatry, Psychology and Epidemiology and the Artificial Heart and Adult Cardiothoracic Transplantation Programs, University of Pittsburgh School of Medicine and Medical Center, Pittsburgh, Pennsylvania
Institute of Nursing Science, University of Basel, Basel, SwitzerlandCenter for Health Services and Nursing Research, Katholieke Universiteit Leuven, Leuven, Belgium
Cardiothoracic transplantation’s success at prolonging life—and its economic costs—must be considered relative to its psychosocial benefits and costs. Moreover, psychosocial outcomes themselves influence long-term post-transplant morbidity and mortality rates. Although psychosocial outcomes—encompassing patients’ physical, psychologic and social functioning, their management of their medical regimen and global quality of life—are the focus of many recent studies, these investigations have yet to yield many evidence-based interventions that are routinely applied to improve patient outcomes. Our goals were to summarize existing work on psychosocial outcomes, delineate areas requiring attention, offer recommendations for steps to advance the field, and thereby provide an impetus for the conduct of clinical trials of interventions to improve these outcomes. We concluded that research must generally shift away from descriptive studies and toward prospective and clinical trial designs to: (a) examine a full range of risk factors and clinical sequelae of patients’ psychosocial status; and (b) evaluate the effectiveness of psychosocial interventions. In addition, these issues must be considered across all cardiothoracic recipients, including not only heart recipients but the less-studied populations of lung and heart–lung recipients, and must include longer-term (5+ years) outcomes than is typical in most work. The importance of adequately sized samples to ensure statistical power, and the need to construct study samples representative of the larger cardiothoracic transplant population, cannot be overestimated. Implementing these changes in research design and substantive focus will ensure that psychosocial outcomes research will have maximum impact on transplant recipients’ clinical care.
Although a substantial literature exists regarding clinical outcomes after adult cardiothoracic transplantation (CTTx), there are considerably fewer data on post-transplant psychosocial outcomes. Psychosocial outcomes encompass recipients’ physical functional and psychologic status, behavioral management of their medical regimen, social functioning and global perceptions of quality of life (QOL). The success of CTTx at prolonging life demands that these outcomes receive careful attention. This is imperative because the outcomes are themselves critical indicators of the utility of CTTx: both its economic costs and its benefits in prolonging life must ultimately be considered relative to the psychosocial costs and benefits of receiving a new organ.
Thus, transplant programs’ ability to maximize patient health and survival may depend in part on their capacity to foster optimal psychosocial outcomes.
Therefore, the Nursing and Social Sciences Council (NSSC) of the International Society for Heart and Lung Transplantation (ISHLT) formed a workgroup to critically evaluate the current state of the science regarding the nature, predictors and clinical sequelae of psychosocial outcomes in adult CTTx, as well as the status of interventions to improve these outcomes. The international workgroup included members from the fields of nursing, psychology, psychiatry, epidemiology and social work. We were charged with: (1) reviewing the literature on adult CTTx psychosocial outcomes; (2) determining gaps in this literature; and (3) formulating specific recommendations to guide future research to significantly advance the field.
To accomplish these aims, we identified 5 major domains of psychosocial outcomes, as shown in Figure 1. In identifying and defining these domains, we adopted a conceptualization
in which the transplant is conceived as generating a series of psychosocial effects that radiate outward through key domains of patients’ lives. Physical and psychologic functioning are the most directly and intimately affected, followed by patients’ behavior in managing the medical regimen, their social interactions, and ultimately their global QOL perceptions.
Figure 1Conceptualization of key post-transplant psychosocial domains and specific outcomes within each. This multidimensional conceptual perspective derives from the larger field of psychosocial and QOL research in the context of chronic illness.
Adapted from Dew MA, Switzer GE, DiMartini AF, et al. Psychosocial assessments and outcomes in organ transplantation. Prog Transplant 2000; 10;239–59. Used with permission.
The empirical literature published between 1980 and 2004 was reviewed via searches of major electronic databases (e.g., Medline, Psychinfo, Cinahl). We focused on English-language articles; however, German, French, Dutch and Italian articles were reviewed by workgroup members fluent in those languages.
The next section summarizes the major results of our review, including references to representative publications; individual, exhaustive reviews of each psychosocial domain are available elsewhere.
The focus and unique contribution of the present review concerns the comprehensive set of conclusions that we generated regarding the methodologic and substantive strengths and limitations of existing literature. These were evaluated by NSSC members at the 2003 and 2004 ISHLT annual meetings, with subsequent revisions. Finally, we present a series of specific recommendations for future research. These recommendations evolved directly from ISHLT annual meeting discussions and were formulated during a series of workgroup meetings.
Summary of major findings from psychosocial outcomes research
Physical Functioning
Both objective measures (e.g., exercise capacity) and subjective measures of physical functioning (e.g., perceived functional status) improve with CTTx.
They frequently describe new physical symptoms that cause distress post-transplant, arising primarily as immunosuppressant side effects (e.g., altered body appearance).
Limited data through the early years after lung transplant (LTx) suggest similarly maintained benefits, whereas heart–lung transplant (HLTx) recipients show renewed impairments over time.
Key predictors/correlates of poorer physical functional outcomes post-transplant are displayed in Table 1. No studies have examined whether physical functional status itself predicts subsequent post-transplant clinical outcomes (Table 2). Four intervention studies that included post-transplant physical functioning outcomes are summarized in Table 3. They provide some evidence of positive effects on exercise capacity but mixed effects for perceived physical functioning.
Table 1Predictors and Correlates of Poorer Functioning in each Psychosocial Domain (with references to representative studies)
Study of relative incidences of psychosocial factors before and after heart transplantation and the influence of posttransplantation psychosocial factors on heart transplantation outcome.
Mood and anxiety disorders, as well as sub-clinical psychologic symptoms, are relatively common in the first year after CTTx (and are even more prevalent than before transplant), but abate over the next several years.
Key predictors/correlates of poorer psychologic functioning post-transplant are displayed in Table 1. Table 2 shows that psychologic disorders and symptomatology themselves predict subsequent clinical outcomes. Of the three intervention studies that considered psychologic outcomes, two noted improvements (Table 3).
Behavior in Managing Post-transplant Medical Regimen
Studies report wide ranges of rates of non-adherence to the CTTx medical regimen, including 0% to 40% for taking medications,
Study of relative incidences of psychosocial factors before and after heart transplantation and the influence of posttransplantation psychosocial factors on heart transplantation outcome.
Study of relative incidences of psychosocial factors before and after heart transplantation and the influence of posttransplantation psychosocial factors on heart transplantation outcome.
Study of relative incidences of psychosocial factors before and after heart transplantation and the influence of posttransplantation psychosocial factors on heart transplantation outcome.
Study of relative incidences of psychosocial factors before and after heart transplantation and the influence of posttransplantation psychosocial factors on heart transplantation outcome.
Study of relative incidences of psychosocial factors before and after heart transplantation and the influence of posttransplantation psychosocial factors on heart transplantation outcome.
Study of relative incidences of psychosocial factors before and after heart transplantation and the influence of posttransplantation psychosocial factors on heart transplantation outcome.
Key predictors/correlates of post-transplant non-adherence are listed in Table 1. Table 2 shows that non-adherence predicts clinical outcomes. The few intervention efforts have obtained mixed effects on adherence (Table 3).
Social Functioning
The majority of CTTx recipients report positive perceptions of interpersonal relationships, social role participation and leisure activities.
Morbidity, functional status, and immunosuppressive therapy after heart transplantation an analysis of the Joint International Society for Heart and Lung Transplantation/United Network for Organ Sharing Thoracic Registry.
due in part to varying definitions of employment. Employment rates appear to increase over time post-transplant. Table 1 displays key predictors/correlates of poorer social functioning, although no study has examined whether social functioning affects clinical outcomes. A single intervention study found some positive effects on social functioning (Table 3).
Global QOL
We considered perceived global QOL as a separate outcome because transplant recipients’ global perceptions are often only modestly related to functioning in other specific psychosocial domains.
Key predictors/correlates of global QOL post-transplant are displayed in Table 1; this outcome has not been considered as a predictor of clinical outcomes. A single intervention trial found no impact on global QOL (Table 3).
Conclusions
Substantive Findings and Areas of Omission in Present Research
Table 4 summarizes the distribution of published data in each psychosocial domain. Although there have been many descriptive studies in most areas of research, there are considerably fewer data on predictors and correlates of CTTx recipients’ psychosocial status. These limited data constitute an important impediment to progress: optimal patient management to maximize psychosocial outcomes is feasible only when we can clearly identify who is at risk for sub-optimal outcomes, and under what circumstances this risk is increased. Finally, little information is available on the impact of most psychosocial domains on post-transplant clinical outcomes, and little progress has been made in evaluating potentially useful interventions. Given even the small amount of literature showing that psychosocial outcomes themselves predict clinical morbidity and mortality, it is imperative to identify intervention strategies to improve post-transplant psychosocial functioning.
Table 4Extent of Empirical Evidence on Nature, Predictors, Clinical Outcomes and Relevant Interventions for 5 Psychosocial Domains in CTTx Recipients
Psychosocial domain
Descriptive information
Predictors/correlates
Predictors of clinical outcomes
Interventions
HTx
LTx
HLTx
HTx
LTx
HLTx
HTx
LTx
HLTx
HTx
LTx
HLTx
Physical functioning
+++
++
+
++
+
+
0
0
0
+
+
0
Psychologic functioning
Psychiatric disorders/distress
+++
+
+
++
+
+
+
+
0
+
+
0
Neurocognitive functioning
+
0
0
+
0
0
0
0
0
0
0
0
Behavior in managing the post-transplant regimen
+++
+
0
++
+
0
+
+
0
+
+
+
Social functioning
Roles and relationships
+++
++
+
+
+
0
0
0
0
+
0
0
Employment
+++
++
+
++
++
0
0
0
0
0
0
0
Global QOL
+++
++
+
++
+
0
0
0
0
0
+
0
Key: +++, extensive amount of data available; ++, moderate amount of data available; +, little data available; 0, no data found.
Table 4 also highlights differences in the current knowledge base across the 5 psychosocial domains. For example, among descriptive studies, there is a notable lack of work on neurocognitive functioning. Among studies of predictors/correlates of psychosocial outcomes, there are fewer data for neurocognitive and social role functioning than for other outcomes. Finally, Table 4 shows that HTx recipients have been studied much more extensively than other CTTx populations.
It is noteworthy that the 5 psychosocial domains themselves encompass many specific outcomes. These outcomes differ dramatically in their coverage in the literature. For example, in the physical functioning domain, there are considerably more data about exercise capacity and perceived physical functioning than about sexual functioning. In the literature on behavior in managing the medical regimen, medication adherence has received the greatest attention. Furthermore, outcomes in all psychosocial domains have been examined primarily in the early, rather than later, post-transplant years.
Methodologic Strengths and Limitations in Present Research
Several encouraging trends are apparent. Increasing numbers of studies in all psychosocial domains provide more complete sample descriptions (e.g., sampling frame, rates of refusal, attrition). There has also been a movement toward larger sample sizes, especially in studies of HTx recipients. Increased sample sizes enable more precise estimates of rates of specific psychosocial outcomes and their associations with other variables. Finally, a growing number of reports utilize standardized assessment instruments with known psychometric properties. This increase in assessment rigor has led to greater understanding of the nature of post-transplant psychosocial outcomes.
A variety of limitations remain, however. Despite increased sample sizes, many studies remain statistically underpowered. When studies report null findings due to lack of power to detect effects (Type II error), potentially important relationships of psychosocial variables with other patient or clinical characteristics are likely to be discounted and not pursued further.
An additional limitation is reliance on samples that are not representative of the patient population under study, or do not include important sub-groups in sufficient numbers to examine them separately. For example, failure to include both genders in studies designed to be generalized to all HTx or LTx recipients, or failure to include representative proportions of ethnic sub-groups, relative to their sizes in the larger patient population at a given center or in a given country, can reduce generalizability.
Although assessment methodologies have improved, continuing conceptual ambiguities exist in defining distinct elements of psychosocial outcomes. The problem is not necessarily the fact that differing definitions of variables are used across studies so much as it is that CTTx researchers do not consistently state how or why they chose to measure some facets of the psychosocial domains and not others. The need for conceptual and measurement clarity in examining these domains is not unique to transplantation; it is an issue for all areas of psychosocial assessment, and it is currently undergoing extensive study within the United States National Institutes of Health roadmap of strategic activities, under the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative.
In the meantime, conceptual and measurement rigor—that is, careful definition of domains to be assessed, and care in instrument selection and administration—requires continued attention in CTTx research to maximize understanding and generalizability of study findings.
With respect to study design, the literature on CTTx psychosocial outcomes continues to rely heavily on cross-sectional strategies, rather than longitudinal or prospective designs that allow for clearer conclusions regarding which variables are predictors or risk factors vs those that are outcomes. This weakness has limited the conclusions that can be drawn about: (a) which patients are truly at risk for poorer psychosocial outcomes; (b) whether these outcomes themselves predict clinical outcomes; and (c) what variables should be targeted for intervention. Concerning the few interventions conducted to date, important study design limitations include the lack of control groups in many of the studies, and (among those with controls) failure to use randomized designs. Both factors reduce the strength of any conclusions that can be drawn.
Recommendations for future psychosocial research
Substantive Issues
1
CTTx psychosocial outcomes research should, with few exceptions (e.g., neurocognitive functioning), shift away from purely descriptive studies and toward longitudinal and prospective studies that examine risk factors and outcomes of CTTx recipients’ psychosocial functioning.
2
Studies that examine risk factors for psychosocial outcomes should place greater emphasis on including a full range of factors believed to be important. This would enable stronger conclusions regarding: (a) the unique impact of particular risk factors relative to others; and (b) whether the combined effects of series of risk factors are additive or synergistic.
3
Greater attention is needed in evaluating the impact of CTTx recipients’ psychosocial functioning on clinical outcomes. A more complete understanding of effects on morbidity and mortality has critical implications for clinical management and intervention to improve clinical outcomes.
4
Trials of promising interventions to maximize psychosocial outcomes must be conducted. Numerous psychologic, behavioral and rehabilitation interventions evaluated in other chronic disease fields are potentially relevant. Some may be easily adapted and tailored to the unique medical and psychosocial concerns in CTTx recipients. Alternatively, novel interventions could be designed based directly on the existing psychosocial outcomes literature in CTTx recipients.
5
Given the generally greater number of studies on HTx recipients, greater focus is needed on psychosocial outcomes for LTx recipients, especially given their improved survival rates.
6
Greater consideration is needed of long-term (5+ years post-transplant) psychosocial outcomes and their determinants for all types of CTTx recipients.
7
Studies must include adequate representation of important patient sub-groups whose outcomes may differ from the majority of CTTx recipients. This would include, for example, adequate representation of women in HTx samples, and adequate representation of ethnic minorities in CTTx samples.
Methodologic Issues
1
Sample composition and sub-group inclusion are also methodologically important. For findings to be generalizable, studies of psychosocial outcomes must enroll subjects from a known sampling frame to ensure representativeness to the larger patient population.
2
Greater attention is needed to evaluating and ensuring that sample sizes are large enough to provide adequate statistical power to address study questions.
3
Increased use of multicenter designs would strengthen the potential for large, representative samples and increase the likelihood that critical sub-group analyses could be performed with adequate statistical power.
4
Studies must adopt state-of-the-art strategies to minimize refusal and attrition rates. These strategies, such as repeat mailings for mailed surveys and interviewer training to develop rapport with subjects, are not uniformly employed in this area of study.
5
Assessment strategies must become even more highly standardized and must derive from clear, explicit definitions of the domains to be measured. A multi-method approach will often be optimal. For example, adherence to the medical regimen is likely to be best assessed through a combination of self-report, informant report and indirect measures (e.g., electronic medication monitoring). Use of novel assessment strategies (e.g., internet-based data collection) may facilitate recruitment, retention and repeated evaluation of subjects.
6
Study designs appropriate for drawing inferences regarding risk factors or causal relationships must be employed. These would include longitudinal, prospective and experimental designs and would largely exclude cross-sectional studies, for which the direction of effects is usually indeterminate.
7
Greater use must be made of analytic strategies that are flexible with regard to missing datapoints, once the nature of the missing data (ignorable vs non-ignorable) has been examined. Such strategies would include not only survival analysis but mixed effects models for repeated-measures data.
8
Effect size information must be routinely reported. These data are critical for the appropriate cumulation of studies’ findings (i.e., meta-analysis) and for evaluation of clinical significance.
9
Intervention studies of strategies to improve CTTx psychosocial outcomes must consist of controlled, randomized trials, with routine blinding of assessors collecting outcome data.
References
Dew M.A.
Switzer G.E.
DiMartini A.F.
et al.
Psychosocial assessments and outcomes in organ transplantation.
Study of relative incidences of psychosocial factors before and after heart transplantation and the influence of posttransplantation psychosocial factors on heart transplantation outcome.
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